Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina.
JAMA Ophthalmol. 2019 Jul 1;137(7):802-808. doi: 10.1001/jamaophthalmol.2019.1203.
In improving clinical outcomes, developing a sustainable, transformative care delivery model is important for accessible, efficient, low-cost, high-quality community-based imaging and diagnosis of retinal diseases.
To test the feasibility and accuracy of the remote diagnosis imaging model as a clinical screening tool to facilitate the identification of referable macular degeneration.
DESIGN, SETTING, AND PARTICIPANTS: A nonrandomized study of 159 patients was conducted in sites with a relatively high disease prevalence (Duke University Health System endocrinology clinic and 2 Duke University Health System assisted living centers in North Carolina). All patients underwent remote diagnosis imaging, defined as color fundus photography (CFP) and optical coherence tomography (OCT) of nondilated pupils, acquired by nonexpert imagers using a retinal imaging device located at the point of service. The criterion standard examination was defined as a traditional dilated eye examination performed by retinal specialists. Deidentified remote diagnosis images were graded for interpretability and presence of referable macular degeneration, defined as any condition requiring a retinal specialist attention. Data analysis was performed from November 20, 2015, to February 10, 2019.
Primary outcome was feasibility of the remote retinal imaging. Secondary outcomes were operational characteristics and diagnostic and referral accuracy.
Of the 159 patients included in the study, the mean (SD) age of enrolled participants was 65 (17) years, with a female to male ratio of 1.3 to 1. Most patients were white (111 [69.8%]), 44 were black patients (27.7%), approximately 1% were Asian patients and Hispanic patients, and 2 patients declined to disclose their race/ethnicity. Thirty-five eyes (22.0%) were determined to require referral to the retinal specialist by criterion standard examination. Remote diagnosis image interpretability was better when OCT was used compared with CFP (241 [96.4%] vs 164 [65.6%]). Remote diagnosis had high diagnostic accuracy in identifying referable macular degeneration: OCT and CFP both had 94% sensitivity (95% CI, 84%-98%), and OCT had specificity higher than for CFP (93% [95% CI, 87%-96% ] vs 63% [95% CI, 53%-71%]). Substantial agreement was found between the criterion standard and OCT (κ = 0.83; 95% CI, 0.76-0.91; P < .001) and between the criterion standard and CFP (κ = 0.76; 95% CI, 0.64-0.87; P < .001). The nonvalidated patient satisfaction survey revealed that 122 participants (76.7%; mean score, 4.16; 95% CI, 3.98-4.35) preferred remote imaging over the standard care examination.
Remote diagnosis imaging and a standard examination by a retinal specialist appeared equivalent in identifying referable macular degeneration in patients with high disease prevalence; these results may assist in delivering timely treatment and seem to warrant future research into additional metrics.
在改善临床结果方面，开发一种可持续的、变革性的医疗服务模式对于可及性、高效、低成本、高质量的社区视网膜疾病成像和诊断至关重要。
测试远程诊断成像模型作为临床筛查工具的可行性和准确性，以方便识别可转诊的黄斑变性。
设计、地点和参与者：在疾病发病率较高的地点（北卡罗来纳州杜克大学卫生系统内分泌科和 2 个杜克大学卫生系统辅助生活中心）进行了一项非随机研究，共纳入 159 名患者。所有患者均接受远程诊断成像，定义为使用位于服务点的视网膜成像设备进行非散瞳彩色眼底照相（CFP）和光学相干断层扫描（OCT）。标准检查定义为由视网膜专家进行的传统散瞳眼部检查。对无法识别的远程诊断图像进行解释性和可转诊黄斑变性的分级，定义为任何需要视网膜专家关注的情况。数据分析于 2015 年 11 月 20 日至 2019 年 2 月 10 日进行。
主要结局是远程视网膜成像的可行性。次要结局是操作特征和诊断及转诊准确性。
在纳入的 159 名患者中，参与者的平均（SD）年龄为 65（17）岁，女性与男性的比例为 1.3:1。大多数患者为白人（111 名[69.8%]），44 名为黑人患者（27.7%），约 1%为亚洲患者和西班牙裔患者，有 2 名患者拒绝透露其种族/民族。根据标准检查，有 35 只眼睛（22.0%）被确定需要转介给视网膜专家。与 CFP 相比，OCT 用于远程诊断图像的解释性更好（241 次[96.4%] vs 164 次[65.6%]）。远程诊断在识别可转诊的黄斑变性方面具有较高的诊断准确性：OCT 和 CFP 的敏感性均为 94%（95%CI，84%-98%），OCT 的特异性高于 CFP（93%[95%CI，87%-96%] vs 63%[95%CI，53%-71%]）。标准检查与 OCT（κ=0.83；95%CI，0.76-0.91；P<0.001）和标准检查与 CFP（κ=0.76；95%CI，0.64-0.87；P<0.001）之间存在高度一致性。未经验证的患者满意度调查显示，122 名参与者（76.7%；平均评分 4.16；95%CI，3.98-4.35）更喜欢远程成像而不是标准护理检查。
远程诊断成像和视网膜专家的标准检查在识别高疾病发病率患者的可转诊黄斑变性方面似乎等效；这些结果可能有助于提供及时的治疗，并似乎值得进一步研究其他指标。
